Significant biosimilar activities this week include:
11 May: AstraZenecaannounced it had recovered the global rights to brazikumab from Amgen. AstraZeneca had previously collaborated with Amgen to jointly develop and commercialise the product. Brazikumab is a monoclonal antibody targeting IL-23 and is currently in Ph II and Ph III trials for the treatment of ulcerative colitis and Crohn's disease. The American Journal of Managed Care reported the development, noting the role the AbbVie-Allergan merger and the FTC played in facilitating the deal. The FTC ruled that as both AbbVie and Allergen were developing IL-23 inhibitors, there would not be a sufficiently competitive environment for these products unless brazikumab was released from Amgen/Allergan.
18 May: Samsung Bioepis announced 24-week interim results from a Ph III trial of SB11 (a proposed ranibizumab biosimilar) in patients with neovascular age-related macular degeneration. Samsung Bioepis announced that the primary endpoints of the trial were met, suggesting that SB11 will be a valuable treatment option for nAMD.
18 May: JHL Biotechannounced that the first group of subjects in the Australian randomised Ph I trials of JHL1266 (proposed denosumab) were dosed.
19 May: Korea Biomedical Review announced that Daewon Pharmaceutical has launched Terrosa® (teriparatide) in South Korea. Terrosa® was developed by Gedeon Richter and is indicated for the treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture, and osteoporosis associated with sustained systemic glucocorticoid therapy in men and women at increased risk for fracture.
22 May: JD Supra reported on Mylan's Q1 earnings call.In the call, Mylan announced its partner Biocon had received FDA pre-approval of its Malaysian manufacturing facility, as well as announcing a planned launch for Nepexto® (etanercept) in Europe within months. The BLA and marketing authorisation for its bevacizumab candidate is currently under review by the FDA and European authorities. Mylan also confirmed that its biosimilar insulin and aflibercept projects remain on target.
22 May: Fresenius Kabi announced that the EMA has accepted its marketing application for MSB11455, a proposed pegfilgrastim biosimilar.